scholarly journals Immunogenicity of influenza vaccines administered to pregnant women in randomized clinical trials in Mali and South Africa

Vaccine ◽  
2020 ◽  
Vol 38 (41) ◽  
pp. 6478-6483
Author(s):  
Avnika B. Amin ◽  
Marta C. Nunes ◽  
Milagritos D. Tapia ◽  
Shabir A. Madhi ◽  
Clare L. Cutland ◽  
...  
Keyword(s):  
South Africa ◽  
Clinical Trials ◽  
Pregnant Women ◽  
Randomized Clinical Trials ◽  
Influenza Vaccines

scholarly journals Sepsis in pregnancy and early goal-directed therapy

2009 ◽  
Vol 2 (3) ◽  
pp. 93-99 ◽  
Author(s):  
Julie Joseph ◽  
Aneeta Sinha ◽  
Michael Paech ◽  
Barry N J Walters
Keyword(s):  
Clinical Trials ◽  
Pregnant Women ◽  
Randomized Clinical Trials ◽  
Surviving Sepsis Campaign ◽  
Goal Directed Therapy ◽  
Early Goal Directed Therapy ◽  
Conventional Management ◽  
Serious Infection ◽  
Underlying Pathophysiology ◽  
In Pregnancy

Sepsis is a major cause of serious morbidity and mortality in pregnant women and their babies. Conventional management has evolved over many years. Improved understanding of the underlying pathophysiology and randomized clinical trials have led to recommendations for the formalization and standardization of the management of severe sepsis in non-pregnant patients. Most of these recommendations are applicable to pregnancy. The Surviving Sepsis Campaign and Early Goal Directed Therapy have relevance to the care of pregnant women with serious infection and are reviewed here.

Opening windows of opportunities: Evidence for interventions to prevent or treat depression in pregnant women being associated with changes in offspring's developmental trajectories of psychopathology risk

2018 ◽  
Vol 30 (3) ◽  
pp. 1179-1196 ◽  
Author(s):  
Sherryl H. Goodman ◽  
Katherine A. Cullum ◽  
Sona Dimidjian ◽  
Laura M. River ◽  
Christine Youngwon Kim
Keyword(s):  
Clinical Trials ◽  
Pregnant Women ◽  
Fetal Programming ◽  
Randomized Clinical Trials ◽  
Programming Model ◽  
Developmental Trajectories ◽  
Meta Analysis ◽  
Experimental Studies ◽  
Behavioral Changes ◽  
Small Effect Size

AbstractAlthough animal models and correlational studies support a model of fetal programming as a mechanism in the transmission of risk for psychopathology from parents to children, the experimental studies that are required to empirically test the model with the human prenatal dyad are scarce. With a systematic review and meta-analysis of the literature, we critically examined the evidence regarding the neurobiological and behavioral changes in infants as a function of randomized clinical trials to prevent or reduce maternal depression during pregnancy, treating randomized clinical trials as experiments testing the fetal programming model. Based on 25 articles that met inclusion criteria, we found support for interventions designed to change maternal prenatal mood being associated with changes in offspring functioning, but with a very small effect size. Effect sizes ranged broadly, and were higher for younger children. The findings enhance understanding of putative mechanisms in the transmission of risk from women's prenatal depression to infants’ vulnerabilities to, and early signs of, the development of psychopathology. We note limitations of the literature and suggest solutions to advance understanding of how preventing or treating depression in pregnant women might disrupt the transmission of risk to the infants.

scholarly journals Lessons learnt from enrolment and follow up of pregnant women and their infants in clinical trials in South Africa, a low-middle income country

Vaccine ◽  
2015 ◽  
Vol 33 (47) ◽  
pp. 6406-6412 ◽  
Author(s):  
Clare L. Cutland ◽  
Marianne Cunnington ◽  
Morounfolu Olugbosi ◽  
Stephanie A. Jones ◽  
Andrea Hugo ◽  
...  
Keyword(s):  
South Africa ◽  
Clinical Trials ◽  
Pregnant Women ◽  
Middle Income Country ◽  
Income Country ◽  
Middle Income ◽  
Lessons Learnt

Heparin Does Not Increase Live Births in Pregnant Women with Previous Unexplained Recurrent Miscarriages: A Systematic Review and Meta-Analysis

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 504-504
Author(s):  
Murtadha K. Al-Khabori ◽  
Zainab S. Al-Hosni ◽  
Hajer M. Al Ghaithi ◽  
Altaf M. Al Maamari ◽  
Wafa S. Bessiso ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Pregnant Women ◽  
Antiphospholipid Antibodies ◽  
Odds Ratio ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Inherited Thrombophilia ◽  
Recurrent Miscarriages ◽  
Live Births

Abstract Abstract 504 Background: The impact of heparin in pregnant women with previous unexplained recurrent miscarriages remains uncertain. The use of heparin in this patient population has been increasing with the hope of improving the rate of live births. We performed a systematic review of the randomized clinical trials addressing this question. Methods: We searched MEDLINE (searched July 1st 2012), CENTRAL (Issue 7 of 12, July 2012), American Society of Hematology (searched July 1st 2012), clinical trials registries (http://clinicaltrials.gov/, searched July 1st 2012), and bibliographies of relevant studies for randomized clinical trials comparing heparin (unfractionated or low molecular weight) to other best care approaches. Use of aspirin was allowed in either study arms. Included patients were pregnant women over 18 years of age with previous recurrent unexplained miscarriages (at least two at any trimester). We performed a meta-analysis using random effects models to estimate the pooled odds ratio. Statistical heterogeneity was calculated by using the I2 statistic. Results: Eight trials proved eligible, five of which provided data from 1141 patients that could be included in the meta-analysis and three of which remain unpublished. Only the subgroup of patients with no antiphospholipid antibodies or inherited thrombophilia was included. There was a total of 839 live births observed. Enoxaparin was used in four trials and nadroparin was used in one trial. All trials randomized patients before the 8th week of gestation. There were 430 live births (among a total of 561 pregnancies) and 409 live births (among a total of 580 pregnancies) in the heparin and other best care treatment arms respectively. The difference between the two treatment arms was not statistically significant with a pooled odds ratio of 1.49 (95% confidence interval: 0.84, 2.66; P = 0.17). There was a substantial heterogeneity among the results of different trials (Chi2 = 14.91, P = 0.005; I2 = 73%). Conclusions: Available evidence suggests that heparin does not increase live births in pregnant women with previous unexplained recurrent miscarriages with no evidence of antiphospholipid antibodies or inherited thrombophilia. Future trials should explore new treatment strategies. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Gestational malaria in Kisangani : Efficacy of Mefloquine vs Sulfadoxine-Pyrimethamine in Intermittent Preventive Treatment : A Study Protocol for a randomized controlled clinical trial

2019 ◽  
Author(s):  
Labama Otuli Noël ◽  
Bosenge Nguma ◽  
Maindo Alongo Mike-Antoine ◽  
Katenga Bosunga Gédéon ◽  
Losimba Likwela Joris ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pregnant Women ◽  
Randomized Clinical Trials ◽  
Democratic Republic ◽  
Placental Malaria ◽  
Intermittent Preventive Treatment ◽  
Preventive Treatment ◽  
Sub Saharan Africa ◽  
Controlled Clinical Trial

Abstract Background : In order to reduce malaria-related morbidity and mortality during pregnancy, WHO recommends : Insecticide-treated mosquito nets, Intermittent Preventive Treatment of malaria in pregnancy, Prompt and effective case management. Nevertheless, several cases of resistance to Sulfadoxine-Pyrimethamine, used in intermittent preventive treatment, and to Chloroquine are reported in sub-Saharan Africa and in the Democratic Republic of the Congo. The prevalence of malaria among pregnant women remains high in Africa in general, and in the Democratic Republic of Congo in particular. This issue leads us to conduct this study, which aims at proposing an alternative to SP for preventing malaria in pregnant women. Materials and methods : From June 1 to October 31, 2019, we enrolled pregnant women from five health facilities in Kisangani for randomized, single-blind controlled clinical trials to compare the efficacy of two intermittent preventive treatment regimens in Kisangani pregnant women, selected before 18 th weeks of amenorrhea. The first regimen consists of 4 doses of Sulfadoxine-Pyrimethamine starting at the selection time and spaced at least 4 weeks during pregnancy. Each dose is made of 3 tablets of 525 mg Sulfadoxine-Pyrimethamine. The second regimen consists of 2 doses of Mefloquine during pregnancy. The first dose is taken at the selection time and the second dose between the 28 th and 32 nd weeks of amenorrhea. Each dose is made of 3 tablets of 250 mg Mefloquine. The efficacy criteria for these two regimens are placental malaria parasitemia, low birth weight of newborn and maternal anemia at delivery. The safety criterion was the occurrence of major side effects. Discussion : There are not enough randomized clinical trials assessing the efficacy of Mefloquine for the intermittent preventive treatment of malaria in African pregnant women, hence the recommendation for clinical trials. The present study is the only one that conducts such assessment in a hyper-endemic area with resistance to Sulfadoxine-Pyrimethamine and Chloroquine. The findings are therefore intended to promote the use of Mefloquine as the best alternative to Sulfadoxine-Pyrimethamine in the intermittent preventive treatment of malaria. Clinical trial registration : PACTR201905899965726. Key words : Intermittent preventive treatment, efficacy, safety, Mefloquine, Sulfadoxine-Pyrimethamine, Kisangani.

L-arginine effect on inflammatory mediators: A systematic review of randomized controlled clinical trials

2019 ◽  
pp. 1-9 ◽  
Author(s):  
Seyed Reza Mirhafez ◽  
Mitra Hariri
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Inflammatory Mediators ◽  
Randomized Clinical Trials ◽  
Randomized Controlled Clinical Trials ◽  
Patients With Cancer ◽  
Reactive Protein ◽  
Randomized Controlled ◽  
Human Adults ◽  
Factor Α

Abstract. L-arginine is an important factor in several physiological and biochemical processes. Recently, scientists studied L-arginine effect on inflammatory mediators such as C-reactive protein (CRP), tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). We conducted a systematic review on randomized controlled trials assessing L-arginine effect on inflammatory mediators. We searched data bases including Google scholar, ISI web of science, SCOPUS, and PubMed/Medline up to April 2019. Randomized clinical trials assessing the effect of L-arginine on inflammatory mediators in human adults were included. Our search retrieved eleven articles with 387 participants. Five articles were on patients with cancer and 6 articles were on adults without cancer. L-arginine was applied in enteral form in 5 articles and in oral form in 6 articles. Eight articles were on both genders, two articles were on women, and one article was on men. L-arginine could not reduce inflammatory mediators among patients with and without cancer except one article which indicated that taking L-arginine for 6 months decreased IL-6 among cardiopathic nondiabetic patients. Our results indicated that L-arginine might not be able to reduce selected inflammatory mediators, but for making a firm decision more studies are needed to be conducted with longer intervention duration, separately on male and female and with different doses of L-arginine.

Sign in / Sign up

Export Citation Format

Share Document